An investigation of a new catheter and pressure monitor system that may help to prevent a complication called compartment syndrome from developing in an injured leg. Compartment syndrome occurs when too much fluid builds up in the muscles of the injured leg. This causes a lot of swelling and increases pressures within the leg that can cause permanent damage muscles and nerves in the leg.

To determine if use of Twin Star catheter with active fluid removal reduces muscle compartment pressure vs Twin Star catheter without fluid removal by comparing the randomized groups. Success will be defined by a p-value less than 0.05 (two-sided). [ Time Frame: fluid removal will be collected & recorded at 2, 4, 8, 16, & 24 hrs after catether insertion. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compares the treatment and control groups on change in perfusion pressure (defined as diastolic blood pressure minus IMP) over time. The randomized groups will be compared with a two-sided p-value less than 0.05 defining success. [ Time Frame: Perfusion pressure will be collected and recorded at 2, 4, 8, 16 & 24 hrs post-catheter insertion ] [ Designated as safety issue: No ]

The CMS consists of an Introducer, Pressure Measurement & Fluid Collection (PMFC) catheter, a Fluid Collection (FC) catheter and Compartment Pressure Monitor. The PMFC catheter removes fluid and monitors pressure via a solid-state fiber optic transducer at the tip of the catheter. The FC catheter only removes fluid and does not have a pressure transducer at the tip. The CMS Monitor senses, displays and records compartment pressure as measured by up to two PMFC catheters. In addition, the CMS Monitor measures subject blood pressure using a provided cuff for calculating the perfusion pressure of the muscle compartment.

Other Names:

Twin Star Monitor

Twin Star Catheters

Device: Compartment Monitoring System with Active Fluid Removal

Compartment Monitoring System with Active Fluid Removal

Other Names:

Twin Star Monitor

Twin Star Catheters

Active Comparator: 2

Compartment Monitoring System (CMS) without fluid removal

Device: Compartment Monitoring System (CMS)

The CMS consists of an Introducer, Pressure Measurement & Fluid Collection (PMFC) catheter, a Fluid Collection (FC) catheter and Compartment Pressure Monitor. The PMFC catheter removes fluid and monitors pressure via a solid-state fiber optic transducer at the tip of the catheter. The FC catheter only removes fluid and does not have a pressure transducer at the tip. The CMS Monitor senses, displays and records compartment pressure as measured by up to two PMFC catheters. In addition, the CMS Monitor measures subject blood pressure using a provided cuff for calculating the perfusion pressure of the muscle compartment.

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681616

Contacts

Contact: Janelle M Antil

651-209-0556 ext fax

Contact: Debbie A Cooper

651-209-0556 ext fax

Locations

United States, California

University of California, Irvine Medical Center

Not yet recruiting

Orange, California, United States, 92868

Contact: Emilia Castaneda 714-456-5759

Principal Investigator: David Zamorano, MD

Sub-Investigator: Marty Tynan, MD

University of California - San Francisco / San Franciso General Hospital